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TWO-WAY FOLEY CATHETER with plastic valve, Tiemann tip
EUDAMEDClass IIa (EU MDR)
Ref CFTL-2D-12-30-P
by ZARYS International Spółka z ograniczoną odpowiedzialnością
Identity
- Trade Name
- TWO-WAY FOLEY CATHETER with plastic valve, Tiemann tip EUDAMED
- Device Name
- sterile Foley catheter EUDAMED
- Model / Reference
- CFTL-2D-12-30-P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907996868865 EUDAMED
- Basic UDI-DI
- B-05907996868865 EUDAMED
- EMDN Code
- U010206 URETHRAL PROSTATIC AND BLADDER CATHETERS, TIEMANN WITH BALLOON EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
TWO-WAY FOLEY CATHETER with plastic valve, Tiemann tip by ZARYS International Spółka z ograniczoną odpowiedzialnością — Class IIa — MDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05907996868865 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- PL-MF-000000410
Sources (1)
- EUDAMED c51c7f04-07fc-4908-8ce3-0d5cbeef7e26 61 fields · synced Oct 8, 2026